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Investigating Lower Limb Trauma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Engineering and Physical Sciences Research Council, UK
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01691950
First received: April 23, 2012
Last updated: October 15, 2013
Last verified: March 2013
  Purpose

This is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. This will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb salvage surgery following a traumatic injury to their lower limb.


Condition
Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Investigating the Outcomes of Lower-limb Trauma Patients

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Functional outcome (consisting of questionnaire score, Hamlyn Mobility Score (HMS) gait/activities of daily living parameters) [ Time Frame: Single Session (up to 1 hour) ] [ Designated as safety issue: No ]
    Participants will be given 3 functional outcome scores from a questionnaire, HMS, and objective kinematic measurements


Secondary Outcome Measures:
  • Participant length of hospital stay, rehabilitation time (if appropriate), and complications. [ Time Frame: Up to length of study (1-2 years) ] [ Designated as safety issue: No ]
    These measurements refer to the participants healthcare journey (which are not affected by the research project). Hospital stay refers to the time around their lower limb trauma and any further admissions. Complications include those related to the lower limb trauma (no complications are likely to arise from the research study).


Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Reconstruction
Those who have undergone limb reconstruction following lower limb trauma
Prosthesis
Those who have undergone amputation and rehabilitation with a prosthesis following lower limb trauma
Control
Healthy volunteers

Detailed Description:

In the setting of severe trauma, the decision whether to amputate or save a limb is common, and extremely difficult to make. Due to improving reconstructive surgical techniques there are currently no clear criteria for amputation. Although limb salvage appears desirable in most situations, numerous articles in the scientific literature have shown that it is associated with increased pain, complications, duration of hospital stay, rehabilitation time, and overall costs. These factors may be acceptable if the patients benefited from improved functional outcome. However, studies comparing amputation to limb salvage consistently report no significant difference in functional outcome between the two groups.

A major limitation in the methodology of the fore mentioned studies is the use of self-reported questionnaires to determine functional outcome. Questionnaires are subjective, and often lack specificity, and therefore may not be truly representative of functional outcome. Furthermore, lack of useful information during long-term post-operative care prevents adaption and optimisation of rehabilitation strategies.

The investigators plan on using a wearable sensor to develop an objective mobility assessment tool for patients having either amputation or limb salvage surgery after lower limb trauma. This would result in a reliable and accurate comparison, which may help healthcare professionals make an informed decision between amputation and limb salvage in the future.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants who have been treated following lower limb trauma at the Imperial College NHS Trust sites will be recruited for this study.

Criteria

Inclusion Criteria:

  • To have sustained a lower-limb trauma and undergone limb salvage surgery OR amputation with fitting of prosthesis

Exclusion Criteria:

  1. Contralateral (or other) limb impairment
  2. 18 > AGE > 65
  3. Currently a hospital inpatient
  4. Psychological disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691950

Locations
United Kingdom
Imperial College NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Engineering and Physical Sciences Research Council, UK
Investigators
Principal Investigator: Richard M Kwasnicki, BSc (Hons) Imperial College London
Principal Investigator: Shehan Hettiaratchy, PhD, FRCS Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01691950     History of Changes
Other Study ID Numbers: CRO1934
Study First Received: April 23, 2012
Last Updated: October 15, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Imperial College London:
Trauma
Limb reconstruction
Amputation
Functional outcome
Sensing

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014